Suspended

Long-Term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855

What is being tested

ABT-126

+ ABT-126

Drug

Who is being recruted

Mental Disorders

+ Schizophrenia Spectrum and Other Psychotic Disorders

+ Schizophrenia

From 20 to 66 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorAbbVie

Last updated: May 2, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

This is a study of ABT-126 in the treatment of cognitive impairment associated with schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).

NCT01834638

Principal SponsorAbbVie

Last updated: May 2, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

268 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 66 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophrenia Spectrum and Other Psychotic DisordersSchizophrenia

Criteria

2 inclusion criteria required to participate

The subject is receiving one or more antipsychotic medications

The subject was randomized into Study M10-855 and completed through Week 26 in that study

4 exclusion criteria prevent from participating

Additional history collected during participation in Study M10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia

The subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ECG) measurements in Study M10-855 that indicates the subject is likely to become medically unstable during the current study

The subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial

The subject is currently taking or is expected to be prescribed any excluded medication without the approval of AbbVie medical monitor

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

ABT-126 low dose

Group II

Experimental

ABT-126 middle dose

Group III

Experimental

ABT-126 high dose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 51 locations

Site Reference ID/Investigator# 95398

Chino, United StatesOpen Site Reference ID/Investigator# 95398 in Google Maps

Site Reference ID/Investigator# 95381

Costa Mesa, United States

Site Reference ID/Investigator# 95400

Escondido, United States

Site Reference ID/Investigator# 95406

Garden Grove, United States

Suspended51 Study Centers